Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery

This study has been terminated.
(Due to a lack of a referal base, study was terminated.)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
First received: October 20, 2005
Last updated: May 24, 2012
Last verified: June 2010

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.

Condition Intervention Phase
Kidney Cancer
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Response rate (complete and partial response) at 6 and 12 months after transplantation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
  • Toxicity as measured by CTC AE v 3.0 100 days after transplantation [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: June 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the efficacy of nonmyeloablative conditioning comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic stem cell transplantation, in terms of 6-month and 12-month response rate, in patients with unresectable metastatic renal cell carcinoma.


  • Nonmyeloablative conditioning regimen: Patients receive fludarabine IV on days -4 to -2 and total-body irradiation (TBI) on day 0.
  • Allogeneic hematopoietic stem cell transplantation (AHSCT): After TBI, patients undergo AHSCT on day 0.
  • Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper until day 81. Patients also receive oral mycophenolate mofetil twice daily on days 0-27 (if patient has a related donor) OR three times daily on days 0-29 and then twice daily on days 30-149 followed by additional tapering until day 180 (if patient has an unrelated donor).

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:

    • Clear cell
    • Papillary
    • Medullary
  • Metastatic disease
  • Not amenable to curative surgery
  • No CNS metastases


Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 6 months


  • Not specified


  • Bilirubin < 2 times upper limit of normal (ULN)
  • AST or ALT < 4 times ULN


  • Creatinine clearance > 50 mL/min


  • LVEF > 35%
  • No symptomatic congestive heart failure


  • DLCO > 40% of predicted OR
  • Total lung capacity or FEV_1 > 30% of predicted


Biologic therapy

  • More than 30 days since prior biologic therapy


  • More than 30 days since prior chemotherapy


  • More than 30 days since prior radiotherapy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00243009

United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Brandon M. Hayes-Lattin, MD OHSU Knight Cancer Institute
  More Information

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00243009     History of Changes
Other Study ID Numbers: CDR0000447207  OHSU-ONC-03077-L  OHSU-1282 
Study First Received: October 20, 2005
Last Updated: May 24, 2012
Health Authority: United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:
recurrent renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Fludarabine phosphate
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2016